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FDA clears Roche automated herpes simplex virus type 1 and 2 tests

The US Food and Drug Administration (FDA) has granted clearance to Roche's automated Elecsys HSV-1 IgG and HSV-2 IgG assays, designed for the determination of IgG class antibodies to HSV-1 and HSV-2 in human serum or plasma of sexually active individuals and expectant mothers.

The assays are desgined for use on the company’s cobas e 411, cobas e 601, cobas e 602 and Modular Analytics E170 analyzers.

The company said the immunoassays are intended for use with its electrochemiluminescence technology, a light detection system that provides low-end sensitivity and broad dynamic measuring ranges.

Roche Diagnostics marketing vice president Randy Pritchard said the automated type-specific herpes tests will enable labs to integrate efficient herpes testing into their existing workflow.

"The approval of the type-specific assays also means healthcare providers now have another tool to give them greater confidence in their diagnosis and overall patient care," Pritchard added.